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What Causes Drug Shortages?

By Stephanie Krein, DVM, DACVAA
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617-541-5048

In recent times, drug shortages have affected most veterinarians both in private practice and academia throughout the United States. Although it seems these shortages are new, they have been occurring often over the last decade (Figure 1).1 These shortages have not only affected veterinary medicine but also have caused major crises in human medicine, from the emergency room to the oncology wards. The causes of drug shortages are multifaceted and at this point very difficult to remedy. Currently, the U.S. is experiencing increasing frequency of drug shortages, and this is causing difficulties for hospitals, physicians, veterinarians, and patients. Patient care is adversely affected both in human and veterinary medicine due to the need to substitute safe and effective drugs with less familiar or efficacious drugs. This article will discuss the factors causing drug shortages and the ways in which supply and demand play a role in the current situation (Figure 2).1

The first and one of the most significant reasons for drug shortages in this country is manufacturing difficulties. There is no simple solution to this problem, as many underlying factors contribute to the difficulties in the manufacturing of drugs, including outdated equipment, a shift in the company’s focus and resources from manufacturing the drug to research and development, loss of personnel, and many other factors.1 Manufacturing plants are often antiquated, leading to faulty equipment and shutdown of certain parts of the plant. When this happens, it brings production on that particular equipment to a standstill, and since the FDA approves only a specific manufacturing line to produce a specific drug, the company cannot use other parts of the plant to produce the drug. When this occurs, the manufacturing plant needs to spend large amounts of money to repair the broken parts or on buying new equipment, which is expensive and takes time. Another cause of delay in manufacturing drugs is antitrust laws that prevent companies from sharing information. These reasons and others can lead to lags in production of drugs and shortages in supply of those drugs.

Shortages in raw materials needed to produce a drug also lead to a disruption in the supply of that particular drug. This becomes particularly problematic when the drug is produced from a single source of raw material or when the supplier discontinues production of the raw material needed.1 Even if the drug is produced by several different manufacturers, the absence of the raw material needed will halt production of that drug completely. The U.S. has become dependent on other countries to supply much of the raw materials needed for several drugs, and if these foreign companies have supply problems, it leads to disruption of the drug supply in the United States. Companies in places such as China, India, or Europe may have to deal with issues such as conflicts, animal diseases, contamination during export, or decreased crop yield that affect the supply of the needed raw materials.1

Drug recalls can lead to a disruption in the supply of a product, especially if it is only produced by one manufacturer. These recalls are usually caused by minor issues at a manufacturing plant and do not usually lead to major lags in medication supplies but can lead to short-term shortages. In addition to recalls, there are periods of time in which demand of a drug increases exponentially, leading to the inability of the supply of that drug to keep up. Demand for certain drugs may increase suddenly due to an outbreak in disease, such as a terrible flu season, or a change in vaccination recommendations.

One of the most frustrating reasons for a drug shortage for clinicians is a manufacturing company’s business decisions. These decisions are oftentimes based on finances or profits, the introduction of a generic version of a drug, patent expiration, expenses of manufacturing issues, or company mergers.2 Unfortunately, generic drugs often seem to be affected; because they do not bring large profits to a company, they are not a focus of that company’s manufacturing supply. Generic drugs are very important to healthcare systems and hospitals, and the lack of production of them leads to rapidly rising costs with which these hospitals cannot cope.

The FDA’s regulatory oversight is often blamed for the drug shortages, but this viewpoint is not shared by the FDA. FDA officials blame manufacturing problems, and their claims are backed by data. The FDA does need to pay close attention to quality control of injectable drugs and make sure manufacturing companies are complying for safety reasons.3 The FDA only has limited staff and at times cannot inspect a manufacturing plant in a timely manner, thereby leading to a lag in the production of a certain drug.1

There are other causes of drug shortages, such as issues with wholesalers or distributors, delays in transportation, poor ordering practices at healthcare facilities, or if too many facilities are using the same distributor in one region. A break in one area of the supply chain will lead to a drug shortage, whether short or long term. Natural disasters can lead to major drug shortages. An example of this occurred in Puerto Rico when a hurricane destroyed a major manufacturing plant, leading to shortages in mainstays in treatment such as morphine, norepinephrine, and saline. The saline shortage caused a huge problem in the treatment of patients because saline is used as flush, a diluent, and as a replacement and maintenance fluid. Although it seems simple to manufacture or compound saline since it is literally salt water, when this occurs outside of manufacturing plants, the chance of contaminants is very high.4

As veterinarians, we make up such a small percentage of the total demand for drugs and other manufactured products that we always fall victim to whatever is occurring in human medicine. There is a chance that the manufacturing of a veterinary-specific product could be affected, and in this case, a shortage would most likely occur due to the lack of additional manufacturing plants available to make that product. It is important that veterinarians and their staff keep a close eye on the stock of their drugs and give themselves ample time to search for alternative sources if they are running low on a particular item. It is also important to familiarize yourself with alternative treatments for specific diseases and become comfortable using unfamiliar drugs. With more and more companies merging with each other, the chances of continued drug shortages continues to rise, and this will most likely be a topic we will be dealing with into the unforeseeable future.

Figure 1. Drug shortages.

 

Figure 2. Causes of drug shortages in the US.

References

  1. Ventola, CL. The Drug Shortage Crisis in the United States. P & T. 2011; 36 (11): 740-757.
  2. Ventola, CL. The Drug Shortage Crisis in the United States. P & T. 2011; 36 (11): 740-757.
  3. Ventola, CL. The Drug Shortage Crisis in the United States. P & T. 2011; 36 (11): 740-757.
  4. Jones, GH, Carrier MA, Silver RT, Kantarjian H. Strategies that Delay or Prevent the Timely Availability of Affordable Generic Drugs in the United States. 2016; 10; 1-17.
  5. Gupta R, Sanket SS, Fox ER, Ross, JS. The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States. Journal of Managed Care & Specialty Pharmacy. 2017; 23 (10): 1066-1076.
  6. Mazer-Amirshahi, M, Pharm D, Fox ER. Saline Shortages: Many Causes, No Simple Solution. The New England Journal of Medicine. 2018; 378 (16): 1472-1474.
  7. Beck, JC, Chen, B, Gordon, BG. Physician approaches to drug shortages: Results of a national survey of pediatric hematologist/oncologists. World Journal of Clinical Oncology. 2017; 8 (4): 336-342.
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